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Determination of the Relative Potency of an Anti-TNF Monoclonal Antibody (mAb) by Neutralizing TNF Using an In Vitro Bioanalytical Method
Published on: September 16, 2017
Development of an LC-MS method for measuring TNF in human vaginal tissue
1Korea Food and Drug Administration, Department of Pharmacology. sunok7@daum.net
Journal of Chromatographic Science
|March 13, 2010
Summary
A new method accurately measures tenofovir (TNF) in vaginal tissue. This validated assay is the first to quantify TNF in human tissues, aiding drug research.
Area of Science:
- Analytical Chemistry
- Pharmacology
- Biomedical Science
Background:
- Tenofovir (TNF) is a crucial antiretroviral drug.
- Accurate quantification of TNF in human tissues is essential for pharmacokinetic and efficacy studies.
- Existing methods may lack the sensitivity or specificity required for human tissue analysis.
Purpose of the Study:
- To develop and validate a sensitive, accurate, and precise liquid chromatography-mass spectrometry (LC-MS) assay.
- To quantify tenofovir (TNF) concentrations in human vaginal tissue.
- To establish the first validated method for TNF determination in human tissues.
Main Methods:
- Tissue homogenization followed by solid-phase extraction (SPE) using a C18 column for sample cleanup.
- Chromatographic separation on a reversed-phase C18 analytical column.
- Detection using electrospray ionization mass spectrometry (ESI-MS) in positive ion mode.
Main Results:
- The assay demonstrated high sensitivity, accuracy, and precision for TNF determination.
- Linear calibration curves were achieved between 1-1,000 ng/mL (r² > 0.999).
- Intra- and inter-day accuracy ranged from 89.7% to 109.4%, with precision from 1.3% to 10.9%.
Conclusions:
- A validated LC-MS/MS assay for quantifying tenofovir in human vaginal tissue has been successfully developed.
- This method provides a reliable tool for pharmacokinetic studies of tenofovir in relevant human tissues.
- This represents a significant advancement, being the first validated assay for tenofovir quantification in human tissues.
